Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 2:58 PM
Study NCT ID:
NCT05884359
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Bundle Branch Area Mapping for Conduction System Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002037', 'term': 'Bundle-Branch Block'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroanatomical characteristics of the target area for Left Bundle lead implantation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Electroanatomical metrics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['left bundle branch block', 'pacemaker', 'physiologic stimulation'], 'conditions': ['Left Bundle-Branch Block', 'Pacemaker DDD']}, 'referencesModule': {'references': [{'pmid': '32666617', 'type': 'RESULT', 'citation': 'Orlov MV, Jahangir A, McKelvey D, Armstrong J, Maslov M, Monin AJ, Koulouridis I, Casavant D, Wylie JV. His bundle pacing insights from electroanatomical mapping: Topography and pacing targets. J Cardiovasc Electrophysiol. 2020 Oct;31(10):2737-2743. doi: 10.1111/jce.14672. Epub 2020 Jul 23.'}, {'pmid': '36152975', 'type': 'RESULT', 'citation': 'Orlov MV, Nikolaychuk M, Koulouridis I, Goldman A, Natan S, Armstrong J, Bhattacharya A, Hicks A, King M, Wylie J. Left bundle area pacing: Guiding implant depth by ring measurements. Heart Rhythm. 2023 Jan;20(1):55-60. doi: 10.1016/j.hrthm.2022.09.013. Epub 2022 Sep 21.'}, {'pmid': '30739495', 'type': 'RESULT', 'citation': 'Orlov MV, Koulouridis I, Monin AJ, Casavant D, Maslov M, Erez A, Hicks A, Aoun J, Wylie JV. Direct Visualization of the His Bundle Pacing Lead Placement by 3-Dimensional Electroanatomic Mapping: Technique, Anatomy, and Practical Considerations. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006801. doi: 10.1161/CIRCEP.118.006801.'}]}, 'descriptionModule': {'briefSummary': 'This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.', 'detailedDescription': 'This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation for standard pacemaker indications at one location (Steward St. Elizabeth Medical Center).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.\n\nExclusion Criteria:\n\n* Recent MI-less than 3 months\n* Recent Percutaneous Coronary Revascularization-less than 2 weeks\n* Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month\n* Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker"}, 'identificationModule': {'nctId': 'NCT05884359', 'briefTitle': 'Left Bundle Branch Area Mapping for Conduction System Pacing', 'organization': {'class': 'OTHER', 'fullName': "Steward St. Elizabeth's Medical Center of Boston, Inc."}, 'officialTitle': 'Left Bundle Branch Area Mapping for Conduction System Pacing', 'orgStudyIdInfo': {'id': 'SEMC'}}, 'armsInterventionsModule': {'interventions': [{'name': '3D Electroanatomical Mapping (NavX)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Implantation of a standard Left Bundle Area pacing lead and pacing device'], 'description': 'To utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. Patients will undergo placement of standard Left Bundle Area pacing leads for routine indications, during the implantation procedure electro-anatomical map of the target area and neighboring tissues will be created. Map characteristics will be analyzed and used intra-operatively to assist with lead placement along with standard pacing metrics and standard X-ray criteria. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Orlov, MD, PhD', 'role': 'CONTACT', 'email': 'Michael.Orlov@steward.org', 'phone': '617-789-3187'}], 'facility': "St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Michael Orlov, MD, PhD', 'role': 'CONTACT', 'email': 'Michael.Orlov@steward.org', 'phone': '617-789-3187'}, {'name': 'Karina Demchuk, BS', 'role': 'CONTACT', 'email': 'karina.demchuk@steward.org', 'phone': '413-219-5207'}], 'overallOfficials': [{'name': 'Michael Orlov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Steward St. Elizabeth's Medical Center of Boston, Inc."}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}